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Nexavar priority review for liver cancer

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA grants priority review for Bayer/Onyx's Nexavar (sorafenib) sNDA for use in hepatocellular carcinoma, the firms announce Aug. 20. Completed in June, the submission is supported by data from the Phase III SHARP trial, which demonstrated that Nexavar extended overall survival by 44 percent in patients with liver cancer versus placebo. If approved, the multikinase inhibitor would be the first FDA-approved therapy for the treatment of liver cancer. The priority review designation sets the user fee date in February 2008. Nexavar was approved in December 2005 for the treatment of advanced kidney cancer (1Pharmaceutical Approvals Monthly January 2006, p. 3)...

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